Compliance In A Box Documentum Deployment Solution
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Compliance In A Box Documentum Deployment Solution

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Compliance In A Box Documentum Deployment Solution Compliance In A Box Documentum Deployment Solution Presentation Transcript

  • Compliance-in-a-Box™ Impact Systems, Inc. Partner: :
  • Presentation Outline
    • 1. Compliance-in-a-Box™
      • Why Compliance-in-a-Box was developed
      • Compliance-in-a-Box overview and philosophy
    • 2. Compliance-in-a-Box SOP Edition
    • 3. Compliance-in-a-Box Submission Edition
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Why?
    • We heard our customers
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box™ (CiB)
    • Developed specifically to provide an ECM solution for regulated industries in the SMB market, or departments within larger enterprises
    • Enterprise content application – jump start ECM with CiB building blocks
    • Cost effective, rapid deployment
    • Methodology based on industry experience
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box™ Philosophy
    • Rapid deployment: ready for Production in less than 4 weeks
    • Pre-configured, templated solution
      • Tightly defined project scope and set of configurations
    • Visible, measurable results in a condensed time frame
      • Embraces Six Sigma principles (small project with visible and measurable results which lends to continuous improvement)
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box™ Philosophy
    • Significantly reduced implementation cost with minimal IT involvement
    • A scalable application across the enterprise, including geographies
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • It’s not about technology but successful organizational adoption of technology Enterprise
  • What is included in the CiB Offering? Flexibility to Select Single or Multiple Components Implementation Services (Configuration Parameters, Validation Framework Templates, Implementation Check List and Project Plan) Software Specifications Hardware Specifications
  • CiB Implementation Services Approach Engagement completed in < 30 days Start End Implementation Project Plan and Check List Configuration Parameters + 1x use of Configuration Tools Validation Framework Templates Best Practice” Implementation Methodology A complete set of Validation Documentation ready for sign-off “ Go Live” Ready Implementation
  • CiB Delivery Options
    • Purchased Hardware:
      • Servers pre built and delivered to the customer site
      • Customer manages and maintains
    • Customer’s Hardware:
      • Tools and ‘Best Practices’ brought to customer
      • Servers built on customer infrastructure
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box
  • Compliance-in-a-Box™ SOP Edition Partner:
  • Challenges
    • Versioning
    • Security model
    • Review and approval routing
    • Regulatory agency compliance
    • Proven, repeatable process
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Enterprise Elements: Life Sciences example June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • What is included in the CiB SOP offering?
    • Documentum Compliance Manager
    • (DCM)
    • +
    • Pre-configurations, documentation templates, validation scripts and implementation services from Impact Systems
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Typical CiB Engagement
    • Requirements Definition
    • Software Installation
    • Configuration
    • Validation
    • ‘Box’ Delivery
    • Knowledge Transfer
    • Project Acceptance & Closure
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box™ in Use
    • An International Health Research Institute
    • Challenge: The client was in the process of deploying a completely new facility, and needed a way to manage SOPs across the organization. A limited budget was available to accomplish this.
    • Solution: The CiB solution was delivered, installed, configured, validated and ready for training in less than four weeks. The customer is planning a phased deployment of EMC Documentum applications. Having CiB in such a short time allowed them to include a system in their design that allows their users a head start in their Documentum Compliance Manager learning curve.
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box™ in Use
    • An International Engineering/Construction Management Company
    • Challenge: Evolve from home-grown systems and paper processes to an enterprise application for a very large government project.
    • Solution: A fully functional, validated, content-ready Documentum Compliance environment was up and running within weeks, providing the customer with a scaleable enterprise application. The CiB solution provided peace of mind that the most recent versions of critical procedures are being adopted and followed immediately, hence reducing risk. Procedural approval times were dramatically reduced from three to five weeks down to one week.
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box™ Submission Edition Partner:
  • Challenges
    • Regulatory agency/eCTD compliance
    • Shorten drug development timelines
    • Getting content under control
    • Legacy content/legal risk
    • Proven, repeatable process
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Everything must be documented and almost everything must be published Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing & Service
    • Process Examples
    • Toxicology Study Planning
    • Resource Allocation
    • Content Examples
    • Toxicology Reports
    • Study Definitions
    • Analysis & Findings
    • IND Submissions
    • Process Examples
    • Batch Content Mgnt
    • Structured Product Labeling - PIM
    • CAPA
    • SOP Management
    • Content Examples
    • GMP Manufacturing & Quality Mgnt
    • Labeling
    • Process Examples
    • Contracts Mgnt
    • Marketing Resource Mgnt
    • Web Content Mgnt
    • Content Examples
    • Promo Materials
    • Packaging
    • Web Site Content
    • Process Examples
    • R&D Collaboration
    • Formulation Mgnt
    • Protocol / Methods Management
    • Content Examples
    • Disease Condition Research
    • Lead Compounds
    • Process Examples
    • eTrial Master File
    • Studies Management
    • eCase Report Form
    • eCTD – Regulatory Submissions
    • Content Examples
    • Clin Study Reports
    • NDA Submission
    • Study Tagging Files
    • Trial Materials
    • Trial Results
    • As of January 1, 2008, companies filing electronic submissions with the U.S. FDA (Food and Drug Administration) must use eCTD format.
    • The EMEA (European Medicines Agency) and several individual member health authorities have made similar claims. All member state authorities are expected to accept eCTD by 2009.
    Enter the eCTD – Electronic Common Technical Document: International Standard for Submissions to Regulatory Agencies
  • Challenges with the eCTD
    • The eCTD is complex.
    • The eCTD will drive internal process change.
    • Electronic document management and eCTD submissions are often treated as completely separate processes.
    • Technology solutions - content management and electronic submission systems - historically have been too expensive for Tier II and Tier III Life Sciences companies.
  • eCTD Business Impact
    • Increased time to market
    • Inefficient, high cost processes
    • Increased risk of non-compliance
    • Increased risk of litigation
  • The Solution?
    • Compliance-in-a-Box Submission Edition
    • Best of Breed Solution Set from EMC, ISI and Impact Systems
  • What is included in the CiB SE offering?
    • Documentum Compliance Manager (DCM)
    • +
    • Leading Regulatory Submission and Publishing Tools from ISI
    • +
    • Pre-configurations, documentation templates, validation scripts and implementation services from Impact Systems
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Compliance-in-a-Box Submission Edition Process Templates, Pre-configuration Tools and Best Practices for Optimized Deployment Compliance Interface Process Services Content Services Repository Services Documentum Compliance Manager Virtual Link Manager EMC Documentum Platform ISIPublishe r eCTDXPress
  • In Summary: CiB Highlight of Features
    • Rapid deployment
    • Hardware and software come fully validated ready for content
      • Includes FDA/OQ reports, optional PQ with training on request
    • Allows for easy upgrades and add-ons
      • Provides an infrastructure that can scale as your organization grows
    • Additional solution features
      • Includes a wide range of additional features, available customizations, services and software tools
    • Requires less money up front
      • Create a monthly payment plan over an extended period
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Why CiB?
    • Best in class: developed jointly by EMC® Documentum and Impact Systems
    • Flexible building blocks to accommodate your needs and priorities:
      • SOP, submissions, batch records, CAPA, forms, labels, etc.
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Why Impact Systems?
    • 6 years as an EMC Documentum Select Services Partner
    • 11 years ECM experience
    • Comprehensive deployment and migration experience
    • Proprietary software tools
      • Q-Config™: Configuration deployment, management and migration software
      • Q-Transfer™: Bulk data content transfer software
      • Q-Scripts™: System validation framework
    June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com
  • Thank you for your time. For More Information: www.impactinfosys.com [email_address] 302.573.6864 x105 June 4, 2009 Confidential & Proprietary ImpactInfoSys.com June 4, 2009 Confidential & Proprietary ImpactInfoSys.com